Hemalatha Selvaraj¹*, Muralikrishnan Dhanasekaran², D. Kumudha³, Kanagaraj Duraisamy⁴

¹Nandha College of Pharmacy, Erode, Tamilnadu, India.

²Department of Drug Discovery and Development, Harrison College of Pharmacy, Auburn University, Auburn, Alabama, USA

³Department of Pharmacy, Karpagam Academy of Higher Education, Coimbatore, India.

⁴Deputy Director of Medical Services, District TB Centre, Erode, Tamilnadu, India.

Background: Tuberculosis is one of the lethal infectious diseases that is prevalent worldwide.  Anti-tubercular drugs (ATT) are the mainstay treatment for tuberculosis.  However, the adverse drug reactions (ADRs) and drug resistance to anti-TB treatments may result in the lengthening of the treatment course, its withdrawal, and treatment failure.

Current Gap in Literature:  The Pattern of adverse drug reactions of anti-tubercular regimens and their effective management in tertiary care teaching hospitals are not well studied.

Aims: The current study investigated the adverse drug effects induced by anti-tubercular medications.

Method: The research was a prospective observational study that was carried out in a tertiary care teaching government hospital in the Tamilnadu district of Erode from December 2021 to May 2022 on patients prescribed an anti-tubercular regimen as part of the National Tuberculosis Elimination Programme.  Naranjo scale for causality and the Hartwig scale for severity was used. SPSS version 20.0 was used for the statistical analysis.

Results: This current research included 301 pulmonary TB patients and according to the Naranjo scale of probability, of a total of 75(24.91%) reported adverse drug reactions definite was 3(4%), 23(30.66%) probable, 46(61.33%) possible, and 3 (4%) doubtful. On the Hartwig severity scale, of the 75 adverse drug reactions, 47 (67.66%) were mild and 28 (37.33%) were moderate. The most common adverse medication reactions (32% of all) were gastrointestinal (GI) difficulties. A significant difference was found between Severity assessment, Outcome of ADR, Management of ADR, and causality assessment (p<0.05).

Discussion:  The current study reveals that early identification, reporting, and management of adverse drug reactions endure keynotes in the treatment of a newly diagnosed TB patient.

Keywords: Adverse drug reactions, Hartwig scale, Tuberculosis, Naranjo scale.